(30 days)
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No
The summary describes a standard automatic blood pressure monitor using the oscillometric method, with no mention of AI, ML, or related concepts.
Yes
The device measures vital physiological parameters (blood pressure and heart rate) to provide health information, which falls under the definition of a therapeutic device designed to aid in monitoring and managing health conditions.
Yes
Explanation: The device "measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method," which are measurements used to diagnose conditions like hypertension or other cardiovascular issues.
No
The device description explicitly states it is a "Full Automatic (NIBP) Blood Pressure Monitor" and measures blood pressure using the "oscillometric method," which inherently requires hardware components like a cuff and pressure sensor. The summary also mentions an "LCD Panel" for readout, further indicating hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health.
- This device measures blood pressure and heart rate directly from the human body using the oscillometric method. It does not analyze any biological specimens.
Therefore, this device falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel. The intended for use of this over-the-counter device is for age 16 and above.
Product codes
74 DXN
Device Description
Full Automatic (NIBP) Blood Pressure Monitor
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
age 16 and above
Intended User / Care Setting
over-the-counter device
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
AUG 2 2 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Chen Health & Life Co., Ltd. 6F, No. 407, Chung Shan Road, Sec. 2 Chung Ho City Taipei Hsien TAIWAN R.O.C.
Re: K012310
Trade Name: HL168D Non-Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulatory Class: Class II (two) Product Code: 74 DXN Dated: June 29, 2001 Received: July 23, 2001
Dear Ms. Chen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce suice in also 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmetic Pro (110) - The general controls provisions of the Act include requirements for annual provisions of atives of atives, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (Frediation I ipproval), while Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopolwaiith the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might
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Page 2 - Ms. Susan Chen
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
nes E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO12310 510(k) Number (if known) :
Device Name : Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL168D
Indications For Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .
The intended for use of this over-the-counter device is for age 16 and above.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription USE ( ) (Per 21 CFR 801.109) OR
Over-The-Counter Use( √ ) ( Optional Format 1-2)
K012310
Division of Cardiovascular & Respiratory Devices
510(k) Number